Calibration Plasma LMW Heparin
FDA 510(k) K030964 · Instrumentation Laboratory CO
510(k) numberK030964
Submission
- Device name
- Calibration Plasma LMW Heparin
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- March 27, 2003
- Decision date
- June 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
| K022682 | Randox C-Reactive Protein CalibratorJIS · Traditional | Randox Laboratories, Ltd. | 11/05/2002SE |
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Questions and answers
When was Calibration Plasma LMW Heparin cleared by the FDA?
Calibration Plasma LMW Heparin (K030964) received a 510(k) decision of Substantially Equivalent on June 6, 2003, 71 days after the submission was received.
What is the product code of K030964?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.